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Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial

Primary Purpose

Parkinson´s Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Gait training executive functions tasks
Gait training alone
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson´s Disease focused on measuring Parkinson´s Disease, Rehabilitation, Cognition

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Idiopathic PD performed by a neurologist specialist in movement disorders;
  • In use of dopaminergic medication;
  • Disease severity of 1 to 3 according to Hoehn & Yahr scale;
  • Absence of other neurological disorders or co-morbidities that may affect gait;
  • Absence of dementia (score above 24 on the Mini Mental State Examination - MMSE);
  • Vision and hearing adequate or corrected to normal;
  • Ability to walk independently;
  • Absence of prolonged off state;
  • Age 50 to 85 years.

Exclusion Criteria:

  • Biomechanical alterations (other pathologies) that could compromise the completion of training;
  • Presence of depression, detected by the Geriatric Depression Scale (GDS-15);
  • Presence of any neurological, auditory or visual deficit that could compromise distracting task performance during gait training;
  • Any changes in drug treatment for PD.

Sites / Locations

  • Brazil Parkinson AssociationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gait training executive functions tasks

Gait training alone

Arm Description

The experimental group will perform a gait training associated with the tasks that require the main executive functions (dual-task condition).

The control group will perform a gait training alone, without associated tasks (single-task condition).

Outcomes

Primary Outcome Measures

Dynamic Gait Index
The scale assesses the ability to adapt the gait during motor tasks with different demands.

Secondary Outcome Measures

Montreal Cognitive Assessment
This scale was developed in order to detect mild degrees of cognitive impairment. The instrument assesses different cognitive domains such as attention and concentration, executive functions, memory, language, visuo-constructive skills, calculations, and orientation.

Full Information

First Posted
July 19, 2012
Last Updated
November 6, 2012
Sponsor
University of Sao Paulo
Collaborators
Coordination for the Improvement of Higher Education Personnel
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1. Study Identification

Unique Protocol Identification Number
NCT01650623
Brief Title
Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial
Official Title
Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Coordination for the Improvement of Higher Education Personnel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare two physical therapy training consisting of gait training that are distinguished by one being associated with tasks that require handling of the main executive functions, performed by individuals with Parkinson's Disease. The investigators hypothesis is that the experimental group (EG), which hold gait training with higher cognitive demands (dual-task condition), will make improvements in the parameters measured (functionality of gait and cognitive ability) to a greater extent compared to the control group (CG), which hold gait training without executive tasks (single-task condition).
Detailed Description
The aim of this study is to compare two physical therapy training consisting of a gait training that are distinguished by one being associated with tasks that require handling of the main executive functions (protocol designed by the same team), performed by individuals with Parkinson's Disease. Both training consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, with the following difference: the experimental group (EG) will hold another 30 minutes of gait training in a dual-task condition associated with distracting tasks that require handling of the main executive functions; the control group (CG) will hold an additional 30 minutes of gait training without associated tasks. It will be a prospective study, single blind, randomized, where 30 patients with PD in stages 1 to 3 on Hoehn & Yahr scale will participate in the study, to be held in Brazil Parkinson Association. Patients will be randomized into an experimental and control group, 15 in each one. The training will consist of 10 sessions, two times per week for five weeks. The executive tasks concomitant with gait training cover the following executive functions: volition, self-awareness, planning, response inhibition, response monitoring and attention. The main outcome measures are: (1) Dynamic Gait Index (DGI), (2) Montreal Cognitive Assessment (MoCA), (3) Trail Making Test A and B, (4) Unified Parkinson's Disease Rating Scale (UPDRS) and (5) Falls Efficacy Scale (FES).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson´s Disease
Keywords
Parkinson´s Disease, Rehabilitation, Cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gait training executive functions tasks
Arm Type
Experimental
Arm Description
The experimental group will perform a gait training associated with the tasks that require the main executive functions (dual-task condition).
Arm Title
Gait training alone
Arm Type
Active Comparator
Arm Description
The control group will perform a gait training alone, without associated tasks (single-task condition).
Intervention Type
Behavioral
Intervention Name(s)
Gait training executive functions tasks
Intervention Description
The training will consist of 10 sessions, two times per week for five weeks, and consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, and another 30 minutes of gait training in a dual-task condition associated with distracting tasks that require handling of the main executive functions: volition, self-awareness, planning, response inhibition, response monitoring and attention.
Intervention Type
Behavioral
Intervention Name(s)
Gait training alone
Intervention Description
The training will consist of 10 sessions, two times per week for five weeks, and consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, and another 30 minutes of gait training alone, without other tasks.
Primary Outcome Measure Information:
Title
Dynamic Gait Index
Description
The scale assesses the ability to adapt the gait during motor tasks with different demands.
Time Frame
05/2013 (Up to ten months)
Secondary Outcome Measure Information:
Title
Montreal Cognitive Assessment
Description
This scale was developed in order to detect mild degrees of cognitive impairment. The instrument assesses different cognitive domains such as attention and concentration, executive functions, memory, language, visuo-constructive skills, calculations, and orientation.
Time Frame
05/2013 (Up to ten months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Idiopathic PD performed by a neurologist specialist in movement disorders; In use of dopaminergic medication; Disease severity of 1 to 3 according to Hoehn & Yahr scale; Absence of other neurological disorders or co-morbidities that may affect gait; Absence of dementia (score above 24 on the Mini Mental State Examination - MMSE); Vision and hearing adequate or corrected to normal; Ability to walk independently; Absence of prolonged off state; Age 50 to 85 years. Exclusion Criteria: Biomechanical alterations (other pathologies) that could compromise the completion of training; Presence of depression, detected by the Geriatric Depression Scale (GDS-15); Presence of any neurological, auditory or visual deficit that could compromise distracting task performance during gait training; Any changes in drug treatment for PD.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siqueira, Ms
Phone
55-11-25788177
Email
parkinson@parkinson.org.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Elisa P Piemonte, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cynthia B Ferrari, PhD Student
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brazil Parkinson Association
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grossmann, President
Phone
55-11-25788177
Email
parkinson@parkinson.org.br
First Name & Middle Initial & Last Name & Degree
Cynthia B Ferrari, PhD Student

12. IPD Sharing Statement

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Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial

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